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Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

ConditionsChildren, OnlyVestibular DisorderVestibular FunctionSensorineural Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-10
SponsorGødstrup Hospital

About this trial

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children in the age of 3-10 years

Uni- or bilateral sensorineural hearing loss > 20 dB bone conduction pure tone average measured at frequencies 0.5, 1, 2, 4 kHz

Written informed consent from the parents.

Disqualifiers

Previous inner ear surgery

Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.

Congenital nystagmus

Compromised eye muscle mobility

Trial population

A prospective, unselected group of children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark. We intend to include all consecutive children fitting the inclusion and exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • video Head Impulse Test

    Diagnostic test

    For v-HIT, the Synapsys v-HIT Ulmer device is used.

  • Cervical Vestibular Evoked Myogenic Potential

    Diagnostic test

    For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

  • Ocular Vestibular Evoked Myogenic Potential

    Diagnostic test

    For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

  • Computerized Dynamic Posturography

    Diagnostic test

    To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.

  • Dizziness Handicap Inventory for patient caregivers

    Other intervention

    DHI is a caregiver-reported 21- item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Children with sensorineural hearing loss5 interventions

Trial outcomes

Primary outcomes

1

video Head Impulse Test (vHIT)

Outcome measures: mean VOR gain

Time frame
Measured at baseline.
2

video Head Impulse Test (vHIT)

Outcome measures: VOR gain asymmetry in percent (%)

Time frame
Measured at baseline.
3

video Head Impulse Test (vHIT)

Outcome measures: description of saccades (overt and covert saccades)

Time frame
Measured at baseline.
4

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Outcome measures: latency P1 and latency N1 in milliseconds (ms)

Time frame
Measured at baseline.

Secondary outcomes

1

Vestibular dysfunction

Prevalence of vestibular dysfunction

Time frame
Measures at baseline
2

Dizziness Handicap Inventory for patient caregivers (DHI-PC):

Outcome measures: Mean total DHI-PC score. DHI-PC is a caregiver-reported 21-item questionnaire. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap.

Time frame
Measured at baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gødstrup Hospital

Lead sponsor

Source ClinicalTrials.gov
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